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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma Clinical research trials and Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma clinical trial. Human subjects often get the best healthcare possible for their Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma  Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
For Condition: recurrent adult brain tumor,adult anaplastic oligodendroglioma
Status: Recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractoryoligodendroglioma after previous chemotherapy, radiation therapy, and/or biological therapy.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory oligodendroglioma. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year, every 3 months for 1 year, every 3-4 months for 2 years, every 4-6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy - Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - Must have received and failed prior standard therapy (i.e., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No severe heart disease - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infections - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - Recovered from any prior surgery Other: - No prior antineoplaston therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StanislawBurzynski, Study Chair, Burzynski Research Institute
Burzynski Clinic *Recruiting*
Houston, Texas, 77055-6330
United States
Recruiting Stanislaw Burzynski 713-335-5697
Additional Information:
Study ID Numbers: CDR0000066509; BC-BT-17
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003472
Other Recurrent Adult Brain Tumor Studies:
1. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
2. Suramin in Treating Patients With Recurrent Primary Brain Tumors
3. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
4. CCI-779 in Treating Patients With Malignant Glioma
5. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
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